Analysis of Salivary Proteins in Young Children as an Device to Improve Caries Risk Assessment

NCT06957509 | Recruiting

• 1 other identifier: 2024-07097-01
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this observational study is to learn if the composition of salivary proteins in 3-year-old children, from communities with documented varying caries risks, can be used to identify future diagnostic predictors for caries risk. The main question to answer is: • Can the host´s salivary protein profile (expression and abundance) show a correlation with the caries prevalence between the individuals in the different study cohorts? Two cohorts of children with different documented demographic characteristics in the region of Stockholm (Sweden) will be examined. Participants will be asked to provide saliva samples and undergo clinical oral examinations conducted by trained dental practitioners.

Conditions

Early Childhood Caries (ECC)

Keywords

early childhood caries; saliva; metaproteins; caries risk assessment

Outcome Measures

Primary Outcomes (1)

• Differential protein expression across caries severity levels

  up to 12 weeks

Study Arms (4)

NC

caries-free children

C

children with clinically detectable caries (initial or manifest)

proteom Järva

proteome of 3-year-old children examined in Folktandvården Järva

proteom Danderyd

proteome of 3-year-old children examined in Folktandvården Danderyd

Eligibility Criteria

• Age: 3 Years - 3 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Children will be recruited in conjunction with their mandatory three-year examination at two of Folktandvården's clinics: Järva (care need area 3-4) and Danderyd (care need area 1-2). Dental care is free for children, and the first oral health status examination by a dentist is routinely performed when the child turns three years old. Therefore, Folktandvården's clinics in Stockholm organize events (3-year-old parties) where the first examination of 3-year-old children is conducted. This is a unique opportunity to simultaneously call in and examine community groups of children of the same age, with comparable environmental and socioeconomic factors. We are therefore aiming for two study cohorts consisting of self-defined populations with calibrated age.

You may qualify if:

• year-old children residing in the areas served by Folktandvården Danderyd and Järva, respectively
• Written consent, signed by both parents (guardians)

You may not qualify if:

• children older than three years
• medication intake, and antibiotic use at the time of examination
• children who have consumed food, drink, or used oral hygiene products within 2 hours before the dental visit
• children who appear uncooperative during saliva sampling

Sponsors & Collaborators

• Karolinska Institutet: lead
• Folktandvården Stockholms län AB: collaborator

Study Sites (1)

Folktandvården Stockholms län AB

Stockholm, Sweden

RECRUITING

Related Publications (8)

• Ruan W, Sun C, Gao Q, Shrivastava N. Metaproteomics associated with severe early childhood caries highlights the differences in salivary proteins. Arch Oral Biol. 2021 Nov;131:105220. doi: 10.1016/j.archoralbio.2021.105220. Epub 2021 Jul 29.

  PMID: 34461447 BACKGROUND

• Belda-Ferre P, Williamson J, Simon-Soro A, Artacho A, Jensen ON, Mira A. The human oral metaproteome reveals potential biomarkers for caries disease. Proteomics. 2015 Oct;15(20):3497-507. doi: 10.1002/pmic.201400600. Epub 2015 Sep 22.

  PMID: 26272225 BACKGROUND

• Paes Leme AF, Bellato CM, Bedi G, Cury AA, Koo H, Cury JA. Effects of sucrose on the extracellular matrix of plaque-like biofilm formed in vivo, studied by proteomic analysis. Caries Res. 2008;42(6):435-43. doi: 10.1159/000159607. Epub 2008 Oct 3.

  PMID: 18832830 BACKGROUND

• Ahmad P, Hussain A, Carrasco-Labra A, Siqueira WL. Salivary Proteins as Dental Caries Biomarkers: A Systematic Review. Caries Res. 2022;56(4):385-398. doi: 10.1159/000526942. Epub 2022 Sep 20.

  PMID: 36116431 BACKGROUND

• Anderson M, Dahllof G, Warnqvist A, Grindefjord M. Development of dental caries and risk factors between 1 and 7 years of age in areas of high risk for dental caries in Stockholm, Sweden. Eur Arch Paediatr Dent. 2021 Oct;22(5):947-957. doi: 10.1007/s40368-021-00642-1. Epub 2021 Jun 9.

  PMID: 34106458 BACKGROUND

• Hemadi AS, Huang R, Zhou Y, Zou J. Salivary proteins and microbiota as biomarkers for early childhood caries risk assessment. Int J Oral Sci. 2017 Nov 10;9(11):e1. doi: 10.1038/ijos.2017.35.

  PMID: 29125139 BACKGROUND

• Bostanci N, Selevsek N, Wolski W, Grossmann J, Bao K, Wahlander A, Trachsel C, Schlapbach R, Ozturk VO, Afacan B, Emingil G, Belibasakis GN. Targeted Proteomics Guided by Label-free Quantitative Proteome Analysis in Saliva Reveal Transition Signatures from Health to Periodontal Disease. Mol Cell Proteomics. 2018 Jul;17(7):1392-1409. doi: 10.1074/mcp.RA118.000718. Epub 2018 Apr 2.

  PMID: 29610270 BACKGROUND

• Vegvari A. Mass Spectrometry-Based Analytical Strategy for Single-Cell Proteomics. Methods Mol Biol. 2022;2420:63-72. doi: 10.1007/978-1-0716-1936-0_6.

  PMID: 34905166 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Saliva samples

Central Study Contacts

Franziska Anna Hetrodt, Dr. med. dent.

CONTACT

+46852488273; franziska.hetrodt@ki.se

Maria Anderson, PhD

CONTACT

+468-123 152 03; maria.anderson@regionstockholm.se

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Study Record Dates

• First Submitted: April 2, 2025
• First Posted: May 4, 2025
• Study Start: April 4, 2025
• Primary Completion: December 1, 2025
• Study Completion (Estimated): December 1, 2027
• Last Updated: May 4, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)